The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235092
• Other study ID #: EC03-02
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: April 25, 2007
• Start date: August 2003
• Est. completion date: March 2006

Study information

• Verified date: April 2007
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

Description:

This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1335
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;

2. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;

3. Ostial lesions;

4. Bifurcations;

5. Target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);

6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;

7. Target lesion stenosis for both lesions is >50% and <100% (visual estimate).

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;

2. Has unstable angina classified as Braunwald A I-II-III;

3. Any of the lesions is an unprotected left main coronary disease with >=50% stenosis;

4. Angiographic evidence of thrombus within target lesion;

5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);

6. Documented left ventricular ejection fraction <=25%;

8. Totally occluded vessel (TIMI 0 level) (applies to both lesions);

9. Prior stent within 10mm of target lesion (applies to both lesions).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cypher Sirolimus-Eluting Stent

• Taxus Paclitaxel-Eluting Stent

Locations

Country	Name	City	State
France	Institut Hospitalier Jacques Cartier	Massy

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

France, 

References & Publications (1)

Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.